Detection of tissue injury using microcurrent.  Device name - Zone Finder

ABSTRACT

This invention detects tissue injury using microcurrent. Repeated tests, standardized with the force gauges will show significantly decreased microcurrent over injured tissue. It is fast, simple, and inexpensive, and directly measures tissue injury.

BACKGROUND OF THE INVENTION Problem Solved

There are no medical devices which specifically and objectively detect soft tissue injury, that is injury of muscles, nerves, fascia, ligaments, tendons, and other non-bone structures. Other diagnostic tests can objectively detect soft tissue injury, but they do so indirectly. MRIs, diagnostic Ultrasound, x-rays, and CT scans can detect edema that occurs secondary to a soft tissue injury, provided that there is a sufficient amount of edema from the injury. However, there is no simple, fast, low-cost, direct method on the market to detect soft tissue injury.

MRI and other imaging instruments are very expensive, slow, and require a lot of training to properly use. Also, they detect many different conditions, and soft tissue injury is something only detected through edema or ruptured tissue. Tissue injury is not directly detected.

This invention simply reports microcurrent numbers from repeated tests, standardized with the force gauges. It is fast, simple, and inexpensive, and directly detects tissue injury.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1—Conceptual design of Zone Finder—front view

FIG. 2—Conceptual design of Zone Finder—side view

FIG. 3—Conceptual design of Zone Finder—internal view

A—Switch to change digital display from microcurrent to force

B—Force LEDs—corresponding to right and left probes

C—LED bar graph displaying microcurrent.

D—Digital display

E—Mode select switch—changes between different calibrations.

F—Power switch

G—Earphone jack

H—Battery

I—Probes

J—Electronic force gauges

K—Switches (up/down) for increasing/decreasing current, volume, or tone.

The A-N labels can be seen on the attached drawings.

DETAILED DESCRIPTION OF THE INVENTION

Currently, there are no medical devices which specifically and objectively detect soft tissue injury, that is injury of muscles, nerves, fascia, ligaments, tendons, and other non-bone structures. Other diagnostic tests can objectively detect soft tissue injury, but they do so indirectly. MRIs, diagnostic Ultrasound, x-rays, and CT scans can detect edema that occurs secondary to a soft tissue injury, provided that there is a sufficient amount of edema from the injury. However, there is no simple, fast, low-cost, direct method on the market to detect soft tissue injury. The invention claimed here solves this problem.

The Zone Finder specifically and objectively detects soft tissue injury, is simple to use, provides a measurement in seconds, and will have a cost in the low thousands. The Zone finder works by pairing electrical and mechanical components. Electrically, the invention measures microcurrent applied through the skin between two probes. Mechanically, force gauges measure the pressure on each probe, allowing for standardization of repeated tests. Research has shown that the microcurrent, measured in microohms, drops significantly over injured tissue, as much as 70%

The claimed invention differs from what currently exists. The invention, named the Zone Finder, objectively detects soft tissue injury at a lower cost and in a shorter amount of time compared to MRI and diagnostic ultrasound. Also, MRI and other imaging techniques detect edema from injury, or possibly tears, not injured tissue which this invention detects.

This invention is an improvement on what currently exists. The invention, named the Zone Finder, objectively detects soft tissue injury at a lower cost and in a shorter amount of time compared to MRI and diagnostic ultrasound. Also, MRI and other imaging techniques detect edema from injury, or possibly tears, not injured tissue which this invention detects.

MRI and diagnostic ultrasound indirectly detect tissue injury. Also, they are very expensive and can be slow.

This invention simply reports microcurrent numbers from repeated tests, standardized with the force gauges. It is fast, simple, and inexpensive, along with directly measuring tissue injury.

The Version of the Invention Discussed Here Includes:

-   -   1. A—Switch to change digital display from microcurrent to force     -   2. B—Force LEDs—corresponding to right and left probes     -   3. C—LED bar graph displaying microcurrent.     -   4. D—Digital display     -   5. E—Mode select switch—changes between different calibrations.     -   6. F—Power switch     -   7. G—Earphone jack     -   8. H—Battery     -   9. I—Probes     -   10. J—Electronic force gauges     -   11. K—Switches (up/down) for increasing/decreasing current,         volume, or tone.     -   12. L Analog force gauges     -   13. M Analog calibration     -   14. N Volume control

The A-N labels can be seen on the attached drawings. L-N apply to the current prototype.

Relationship Between the Components:

1—A switch to change digital display (D) from microcurrent to force.

2—Two lines of force LEDs, corresponding to electronic force gauges (10) attached to right and left probes (9).

3—An LED bar graph displaying microcurrent in microohms.

4—Digital display—for displaying microcurrent and other information.

5—Mode select switch—to change between calibrating microcurrent, force, volume, and tone.

6—Power switch—on and off

7—Earphone jack—for use with standard headsets.

8—Battery—9 volt to power instrument

9—Probes—two conductive metal probes. Holes in the tips allow the probes to hold cotton pads.

10—Electronic force gauges—measure force on each probe

11—Switches (up/down) for increasing and decreasing current, volume, or tone

12—Analog force gauges—attached to probes on prototype

13—Analog calibration—for microcurrent on prototype

14—Volume control—analog on prototype.

How the Invention Works:

The microcurrent, the meter, and the probes are necessary. The pads on the probes are optional, but are used for sanitary reasons. Improved force gauges and the housing, allowing for different angles, would improve the invention. Different sized probe housing units would also improve the invention, allowing for use on different sized body parts. Improved force gauges, able to break force into x, y, and z components would also improve the invention. Ideally, force gauges would allow a user to deliver force into the tested area and separating the probes, while eliminating any forces perpendicular to the plane of the probes.

There could be different housings for the probes, including but not limited to different sizes, force gauges, multiple force gauges, probe angles, material used for probes, material used for housing, handgrips and finger pads on the housing, comfort grips on the probes, different materials for wiring, and micromachined force sensors. There could also be different angles for the probes. For the electrical components, changes include but are not limited to microcurrent ranging from 0-1000 microamps, DC current, AC current, square wave current, medium frequency current, and different displays including but not limited to plasma, backlit LCD, non-backlit LCD, LED displays, and analog gauges. Current measurements changes could include but are not limited to electrical conductance, electrical resistance, complex impedance, electrical impedance, electrical current, microcurrent, phase angle, and reactance.

How to Use the Invention:

When the invention is used, the mechanical and electrical components are connected by electrical leads. Cotton pads are inserted into the probes and wet with a conductive solution, generally 0.9% saline. First the microcurrent is calibrated to 100 microamps while shorting the two leads with an external conductive material, such as a wire or sheet of copper. The probes are then moved and applied directed to skin over a body part with and equal force on each probe, and the force being 0.5-1.5 pounds of pressure. Microcurrent then flows through the skin from probe to probe. The digital display reports the microcurrent measurement and the speaker. The force gauges allow pressure to be consistent for repeated measurements.

Measurements are taken over both injured and uninjured areas. A clinician should start at an uninjured area, take a reading, then move towards the suspected injured area an inch or so. Research has shown no significant decrease in microcurrent with a change of 1 inch. Continue these repeated measurements all across the suspected injured area. Ideally, microcurrent should decrease over the injured area, then rise again over healthy tissue. A clinician should draw lines with a pen around the When the invention is used, the mechanical and electrical components are connected by electrical leads. First the microcurrent is calibrated to 100 microamps while shorting the two leads with an external wire or sheet of copper. The probes are then moved and applied directed to skin over a body part with and equal force on each probe, and the force being 0.5-1.5 pounds of pressure. Microcurrent then flows through the skin from probe to probe. The digital display reports the microcurrent measurement and the speaker emits sounds proportional to the microcurrent. The force gauges allow pressure to be consistent for repeated measurements.

In addition the probes previously described, the Zone Finder can use twin probes, each the size of a pencil. These replace the mechanical component and the probes with the force gauges. Either the twin probes or the mechanical component are plugged into the electrical component. This is a redundancy for situations where the force gauged probes may not be sufficiently functional, say for a finger that is smaller than the separation distance of the housed probes.

Therefore, the purpose of this invention is to detect inflammation and/or injury by transmitting and measuring electrical current. The transmitted current is including, but not limited to direct current (DC), alternating current (AC), microcurrent, and other wave forms of electrical current. Measurement is of the following, but not limited to microcurrent, electrical impedance, conductance, resistance, and complex impedance. The measurement is conducted through skin that has been stretched by methods including, but not limited to mechanical stretch, angular probes, force applied at an angle, physical deformation, and conformational change.

Current research has shown a statistically significant average drop of 70% over a known injury compared to an adjacent uninjured area on the same subject or the same area on the opposite limb. It is important to note that this is a comparative number. Each individual person may have a different baseline microcurrent measurement, but current research shows only a 10%-30% change over a particular body part with repeated measurements. For an injured area, the drop occurs when comparing measurements with the location of probes only shifted by an inch. Research has shown no statistically significant change that occurred as a result of changing location by an inch.

The mechanism of this change is cellular damage as a result of hypoxia. Previous research has shown electrical resistance change as a result of ischemia, decreased blood flow. Also, cellular damage resulting from ischemia is from hypoxia, the lack of oxygen. Previous research has also shown that tissues surrounding a wound will experience ischemia and hypoxia due to the fact that the wound draws more of the blood circulation.

Current research has replicated this by showing statistically significant decreases in measured microcurrent five minutes after induced ischemia, and that decreases continue thirty seconds after the ischemic condition is removed. This shows that microcurrent changes are due to cellular damage and not blood flow, as blood flow greatly increases in those thirty seconds.

Since there are few situations where an injured individual will also experience ischemia from external sources, the ischemic damage will be due to injury in a vast majority of cases. Thus, a decrease in microcurrent measurements over baseline measurements in the same subject is a method to detect areas of soft tissue injury.

The invention also serves as an outcome measurement to show healing by showing areas with decreased microcurrent rising over a treatment plan.

How to Make the Invention:

To make this invention, one must first assemble the electronic components. Electric current must be measured as it flows from one probe to the other by a meter, including but not limited to digital and analog meters. The probes must be conductive, including but not limited to metals. Current must only flow when an external surface connects the flow. There also must be a mechanism to connect the probes to allow for calibration. Mechanically, the probes must be attached to force gauges, including but not limited to electronic and mechanical gauges. These force gauges must measure the pressure applied to each probe. The probes are tipped with a disposable pad, including but not limited to cotton and cloth. An audio tone is produced, with the tone changing proportionally based on the quantity of microcurrent flow. The probes are mounted in a housing to standardize the distance between probes and the angle of the probes. Twin probes can also be attached to the microcurrent meter, removing the mechanical component, but still allowing the microcurrent to be measured.

injured area. Repeat this procedure until the injured area is completely demarcated. It is important to use consistent pressure on the probes with the repeated measurements. See attached flowchart for more information.

Additionally: The invention is primarily for use in healthcare. Along with detection and demarcation of soft tissue injury, its uses can be beneficial in the medical-legal area. For example, it can detect whether or not someone has been injured in a rear end car accident or in a workplace incident. By detecting soft tissue injury, this invention can objectively say whether a person has been injured if the injury was not sufficient to cause tearing or fracture of bones or other tissue. 

Having described our invention, we claim:
 1. A device, the Zone Finder, which detects soft tissue injury by both reporting microcurrent readings, with a visual gauge and sound, which decrease as a result of soft tissue injury. A device, the Zone Finder, which detects soft tissue injury.
 2. (canceled)
 3. A device, the Zone Finder, that where the microcurrent readings, as recited in #1, can be calibrated, eliminating irregularities between cotton pads. A device that where the microcurrent readings, as recited in #2, can be calibrated, eliminating irregularities between cotton pads.
 4. A device, the Zone Finder, with force gauges which can be read by a clinician, allowing for reproducible pressure on the probes. A device with force gauges which can be read by a clinician, allowing for reproducible pressure on the probes. 5-7. (canceled)
 5. A device that gives audio feedback proportional to microcurrent readings.
 6. A device where the audio feedback, as recited in #5, can be calibrated.
 7. A device that can show changes in soft tissue injury over time, thus showing healing. 